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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BONECUTTER, 5.5MM, PLATINUM SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. FULL RADIUS BONECUTTER, 5.5MM, PLATINUM SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 72202530
Device Problem Device Slipped (1584)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/27/2017
Event Type  Malfunction  
Event Description

It was reported that during an arthroscopic knee procedure (in the knee joint): flakes have come loose from the full radius bonecutter. The loose flakes are removed from the knee. No procedure delay or patient injuries were reported.

 
Manufacturer Narrative

One 72202530 full radius 5. 5mm bonecutter platinum blade reported on. The complaint stated ¿it was reported that during an arthroscopic knee procedure (in the knee joint): flakes have come loose from the full radius bone cutter. The loose flakes are removed from the knee. No procedure delay or patient injuries were reported¿. The device was not returned yet, although the customer has forwarded a photo. Initial evaluation indicates skiving wear bands on the inside of the outer blade. Shedding has been found to be consistent with wear bands created from inadvertent excess side loading pressure being applied to the device.

 
Manufacturer Narrative

The device was initially evaluated based upon information reported and customer photo. Initial evaluation still applies. Indications of surface skiving on the inside of the outer blade were physically confirmed. It was also confirmed that there are several locations of rotational material skiving on the outer surface of the inner blade. Shedding has been found to be consistent with inadvertent excess side loading pressure being applied to the device. Excessive ¿side-loading¿ on the blade during use does not improve cutting performance and in extreme cases may result in wear and degradation of the inner assembly. Irreversible damage to blades or burrs will result if they are run without the flow of irrigation (dry). Platinum; of the silver family, has been listed as bio-compatible. Platinum has been used to improve performance of the device and does not have an adverse effect on patient safety. No further actions pursued at this time. If relevant information becomes available to assist with evaluation, the complaint will certainly be revisited.

 
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Brand NameFULL RADIUS BONECUTTER, 5.5MM, PLATINUM
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
Manufacturer (Section G)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
Manufacturer Contact
jim gonzales
7000 west william cannon drive
austin, TX 78735
MDR Report Key7152179
MDR Text Key96052806
Report Number1219602-2017-01605
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 03/22/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/28/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device EXPIRATION Date03/08/2020
Device MODEL Number72202530
Device Catalogue Number72202530
Device LOT Number50684163
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/16/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/19/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/08/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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